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临床试验/NCT06385600
NCT06385600尚未招募不适用

Intravenous Labetalol Versus Phentolamine for the Management of Severe Preeclampsia , Randomized Controlled Clinical Trial

Assiut University0 个研究点目标入组 200 人开始时间: 2024年5月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
the effect of Labetalol and Phentolamine on MCA flow velocity by transcranial Doppler monitoring.

研究概览

简要总结

The only effective treatment of severe preeclampsia is delivery of the fetus but immediate antihypertensive treatment is given to stabilize the patient and prevent further complications. All antihypertensive medication can potentially cross the placenta. At this time, there are no randomized control trials to base a recommendation for the use of one antihypertensive agent over another. However, certain medications are effective in lowering blood pressure with an acceptable safety profile in pregnancy. The choice of therapy depends on the acuity and severity of hypertension

详细描述

Non-invasive assessment of cerebral haemodynamics using Transcranial doppler ultrasonography has recently gained importance. Essentially, TCD measures flow velocity in the insonated vessel and the changes in flow velocity can be taken to reflect the changes in blood flow, assuming that the diameter of the insonated vessel remains constant. As TCD is easy to use and gives reproducible measurements, it has become a widely accepted method of assessing the cerebrovascular reactivity to carbon dioxide (CRCO2), cerebral autoregulation, estimated CPP, and CrCP. In patients with neurological disorders, impairment in both cerebral autoregulation and cerebral vascular reactivity has been shown to predict poor neurological outcome. Knowledge of the effects of normal pregnancy and pre-eclampsia on cerebral haemodynamics is essential for appropriate management of these patients undergoing anaesthesia or in labour, particularly when vasoactive medications are administered. The effects of pregnancy and/or pre-eclampsia on MCAFV have been studied by other investigators. Ikeda and colleagues found little change in mean MCAFV during the first two trimesters but reduced values in the third trimester. Williams and Wilson showed that MCAFV fell significantly with advancing gestational age. In another study, Williams and Wilson used TCD to assess cerebral haemodynamics in 17 non-pregnant women, 17 normotensive pregnant women, 20 pregnant women with pre-existing hypertension, and 21 pre-eclamptic women. The pregnant women were all in their third trimester. There was no difference in mean MCAFV in healthy pregnancy compared with non-pregnant women and a small, but non-significant, increase in mean MCAFV in the hypertensive and pre-eclamptic women. Demarin and colleagues studied pre-eclamptic women before and after delivery and found a progressive increase in MCAFV during late pregnancy. Ohno and colleagues compared MCAFV in 35 healthy pregnant and 17 pre-eclamptic women. In this study, the mean MCAFV was significantly higher in the pre-eclamptic group. It has been suggested that these increases in MCAFV are because of a degree of vasospasm. The differences between the findings of various studies with regards to the changes in MCAFV in pre-eclampsia might be explained by the differences in the severity of pre-eclampsia between the studies. Some investigators have reported increased MCAFV in symptomatic, compared with asymptomatic pre-eclamptics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • • Pregnant woman with severe preeclampsia diagnosed by obstetric doctor
  • Patients willing to participate in the study
  • Age above 18 yrs

排除标准

  • • Patients with eminent eclampsia
  • The history of optic neuritis
  • Severe myopia
  • History of ocular surgeries
  • Presence of ocular ulcers
  • Any clinical or morphological conditions that prevent the ultrasound examination of the orbital area
  • Age below 18 yrs

研究组 & 干预措施

labetalol in the managment of severe preeclampsia

Active Comparator

labetalol intravenous infusion (Trandate, Gsk) in a concentration of 10 mg/ ml, thus 50 mg/ml equals to 5 ml/hr. The starting infusion rate of the antihypertensive medication is 5 ml/hr for an 80 Kg patient

干预措施: Labetalol (Drug)

phentolamine in the managment of severe preeclampsia

Active Comparator

phentolamine intravenous infusion (Rogitamine) in a concentration of 10 mg/ml, thus 1 µg/Kg/min equals to 4.8 ml/hr for an 80 Kg patient

干预措施: Phentolamine (Drug)

结局指标

主要结局

the effect of Labetalol and Phentolamine on MCA flow velocity by transcranial Doppler monitoring.

时间窗: 6 hours

Singleton pregnant women who suffered from late onset preeclampsia will be enrolled and subjected to baseline Transcranial doppler (TCD) evaluation to measure middle cerebral artery (MCA) blood flow indices including mean flow velocity (cm/s).

次要结局

  • The effect of labetalol and phentolamine on blood pressure of the patients(6 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Sayed Mostafa

principle investigator

Assiut University

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